InflaRx N.V. (NASDAQ: IFRX) surged into today’s session after unveiling topline Phase 2a data for its oral C5aR inhibitor INF904 in hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU), alongside filing its third‑quarter Form 6‑K showing €44.4 million of available funds and a cash runway into 2027. The company also set out next steps: a Phase 2b HS trial targeted to start in 2026 and continued partnering discussions to accelerate development across indications.
What InflaRx reported today
- Study design: An open‑label, multi‑center Phase 2a “basket” study of INF904 dosed for 4 weeks followed by 4 weeks off‑drug (8‑week total), with efficacy assessed as exploratory endpoints and safety/PK/PD as primary objectives. Topline efficacy was shared for 29/31 HS patients and 30/31 CSU patients who completed treatment. No serious adverse events were reported across the cohorts summarized. [1]
- HS (hidradenitis suppurativa): Across 60 mg BID, 90 mg BID, and 120 mg BID dose groups, InflaRx observed rapid, clinically meaningful reductions in abscesses & nodules and draining tunnels, HiSCR responses that deepened 4 weeks after stopping therapy, and substantial skin‑pain improvements (NRS30). Effects appeared strongest at 120 mg BID among the assessed cohorts. [2]
- CSU (chronic spontaneous urticaria): In patients completing 4 weeks, the UAS7 improved broadly, with numerically greater change in the 60 mg BID cohort (e.g., –13.7 points at Week 4) and evidence of durability through Week 8 off‑drug. Improvement held across high‑IgE and low‑IgE subgroups, and no safety signals of concern were detected. [3]
- What’s next: InflaRx is prioritizing Phase 2b in HS for 2026, continuing CSU development and actively engaging potential collaborators to expand INF904 across inflammatory disorders. The company hosted a webcast today at 8:00 a.m. ET / 2:00 p.m. CET to discuss the data. [4]
The numbers investors will care about (Q3 2025 6‑K)
- Liquidity:€44.4M available funds at Sept. 30, 2025 (€6.4M cash & cash equivalents; €37.9M marketable securities). Management states runway into 2027. [5]
- P&L snapshot: For the nine months ended Sept. 30, 2025, InflaRx reported an operating loss of ~€35.4M and a net loss of ~€35.0M. Reported revenue for the period was ~€63k (GOHIBIC‑related), with a gross loss reflecting cost‑of‑sales and inventory dynamics. [6]
Why this matters
- First look at oral C5aR in dermatology from InflaRx: INF904 aims to block C5a‑receptor signaling, a pathway implicated in neutrophil‑driven and mast‑cell‑mediated inflammation that underpins HS and CSU. Today’s dataset suggests biologic‑like activity over a short 4‑week course and possible off‑drug durability, supporting dose selection and design for the planned Phase 2b. (INF904’s mechanism and program overview here.) [7]
- Pipeline repositioning: After discontinuing the vilobelimab Phase 3 in pyoderma gangrenosum earlier this year, InflaRx has shifted focus to INF904 while maintaining GOHIBIC (vilobelimab) for COVID‑19 ARDS (EUA in the U.S.; EU marketing authorization granted in January 2025). [8]
Market reaction (Nov 10, 2025)
- Pre‑market momentum: IFRX appeared on Nasdaq’s most‑active list pre‑market and drew coverage describing a sharp rise following the INF904 headline. [9]
- Context: Shares regained Nasdaq minimum bid compliance in September, and the company has telegraphed an HS Phase 2b start and potential partnering as 2026 catalysts. [10]
Key data points from the press release (topline)
HS (Week 4 unless noted):
- HiSCR50: 28% across all doses; Week 8 off‑drug (n=25): 44%, with the 120 mg BID cohort showing 63%.
- Total inflammatory burden: meaningful drops in AN and dT counts; NRS30 skin‑pain responders ~66% across all doses; DLQI improvements.
- Safety (n=33):No SAEs; 3 mild treatment‑related AEs in 2 patients. [11]
CSU (Week 4 unless noted):
- UAS7 change:–13.7 at 60 mg BID, –7.9 at 120 mg BID; Severe CSU subgroup: –15.4 (60 mg) vs –8.8 (120 mg). Week 8 off‑drug (n=23): –16.3 at 60 mg.
- UCT7 control: Mean +4.9; UCT7 ≥12 in ~29% overall.
- Safety (n=33):No SAEs; 1 mild treatment‑related AE. [12]
Caveats: The Phase 2a open‑label design, small cohorts, and exploratory efficacy endpoints limit cross‑trial comparisons. The company’s comparisons to other therapies are not head‑to‑head and were flagged as context‑only. [13]
Company timeline & today’s events
- Today (Nov 10): Topline INF904 Phase 2a data released; webcast at 8:00 a.m. ET / 2:00 p.m. CET (replay on the company’s site). Q3 2025 6‑K with financials and MD&A posted pre‑market. [14]
- 2026 (planned):Phase 2b in HS; continued CSU development potentially with partners. [15]
What to watch next
- Dose & design choices for the HS Phase 2b (duration beyond 4 weeks; maintenance vs induction; pain and draining‑tunnel endpoints). [16]
- Partnering outcomes for CSU and broader inflammatory indications for INF904. [17]
- Capital strategy & runway: Management guides into 2027 on current funds; changes will depend on trial scope and any business development. [18]
- GOHIBIC trajectory: EU authorization under exceptional circumstances in January 2025 and U.S. EUA remain background revenue opportunities and strategic optionality. [19]
Quick takeaways
- INF904 hit encouraging signals in both HS and CSU over 4 weeks, with off‑drug durability and clean safety so far. [20]
- IFRX shares spiked pre‑market on the news and were among Nasdaq’s most active this morning. [21]
- Q3 filing: €44.4M available, runway into 2027; YTD 2025 net loss ~€35.0M, typical of a clinical‑stage biotech pivoting toward a larger Phase 2b program. [22]
Disclosure: This article is for informational purposes only and does not constitute investment advice.
References
1. www.inflarx.de, 2. www.inflarx.de, 3. www.globenewswire.com, 4. www.globenewswire.com, 5. www.sec.gov, 6. www.sec.gov, 7. www.inflarx.de, 8. www.inflarx.de, 9. www.nasdaq.com, 10. www.inflarx.de, 11. www.inflarx.de, 12. www.globenewswire.com, 13. www.inflarx.de, 14. www.globenewswire.com, 15. www.inflarx.de, 16. www.inflarx.de, 17. www.inflarx.de, 18. www.sec.gov, 19. www.ema.europa.eu, 20. www.globenewswire.com, 21. www.nasdaq.com, 22. www.sec.gov
